Device and method for applying large-diameter ligating loop

ABSTRACT

A suture applying device comprises an elongate shaft having a length of suture therein. A pre-tied loop suture is held at the distal end of the shaft with a free end of the suture being attached within a handle secured to the proximal end of the shaft. In a first embodiment, a pulley and puller assembly is provided for closing the pre-tied suture loop, where the pulley permits a greater length of suture to be taken in than is traveled by the puller. In a second embodiment, a pair of opposed jaws are slidably mounted within the handle for selectively engaging and gripping the free end of the suture. In this way, an arbitrarily large length of suture may be taken in by pulling on the free end of the suture in successive strokes. The device further includes a sheath slidably disposed on the shaft for protecting the suture during introduction. The sheath automatically retracts when the device is introduced through a trocar sleeve or cannula, thereby exposing the suture loop.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part application of patentapplication Ser. No. 07/958,909 filed Dec. 9, 1992, now U.S. Pat. No.5,300,078.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to devices and methods forligating body structures and, more particularly, to devices forpositioning a preformed ligating loop around the body structure andtightening the loop using a device which can be manipulated with asingle hand.

Pre-tied ligating loops are utilized in surgical procedures for avariety of purposes. Most commonly, the ligating loops will be placedaround the outside of a severed body lumen, such as a blood vessel orthe cystic duct, tightened by pulling on a free end of the ligature, andsevered using separate severing shears. Usually, the ligating loop willbe mounted on the end of a rod or tube so that the surgeon may hold theknot in place with the tube while pulling on the free end of theligature to tighten the loop.

One form of a ligating loop applier comprises a hollow tube carrying theligating loop at its distal end. The free end of the suture is threadedproximally through the lumen of the tube and secured to the proximal endof the tube. A small section of the tube near the proximal end isweakened so that it may be easily broken off by the surgeon. By breakingthe proximal end off, and pulling proximally on the suture, the ligatingloop at the distal end of the tube may be tightened.

While such ligating loop appliers are commonly employed in surgery,including laparoscopic surgery, they suffer from requiring two hands foruse, i.e. a first hand to hold the suture applying tube and a secondhand to break off and pull on the proximal end of the tube. Manipulationis further complicated by the need to use a stainless steel tube toprotect the loop as it is being introduced through a conventional trocarsleeve of the type used in laparoscopic surgery. Additionally, use ofsuch loop appliers has generally been limited to insertion throughconventional 5 mm trocar sleeves which have been pre-positioned atparticular locations in the body. The number and size of such trocarsshould be minimized in order to minimize trauma. It would often bedesirable to insert the loop appliers through other locations withoutthe need to position additional trocar sleeves or to withdraw otherinstruments which are already in place in the existing trocar sleeves.

It would therefore be desirable to provide improved suture applyingdevices which can be manipulated using a single hand, including bothplacement of the loop about a target body structure and tightening ofthe loop using only the single hand. Most desirably, the device could beintroduced through a cannula of reduced diameter to minimize trauma.

A useful design for such a "single-handed" ligating loop applier wouldemploy a three-finger actuating assembly, including an actuator which isengaged by the users middle and index fingers and a thumb rest at theproximal end of the device. By attaching the free end of the suture tothe actuator, the user could first position a ligating loop held at thedistal end of the device at a desired target location and thereaftertighten the loop by translating on the actuator by closing the middleand index finger in opposition to the thumb. Such a design, however,suffers from the drawback that the loop-closing stroke is limited inlength so that pre-tied loops of only about 2-3 cm in diameter can beclosed.

To overcome such a limitation on loop size, it has been proposed that apost be placed on the puller of the ligature applying device and thatthe free end of the suture be wrapped about the post with the end tiedto a portion of the device which remains stationary relative to thepuller. When the puller is drawn proximally, a length of suture equal totwice the length of translation will be drawn in. In this way, largerligating loops can be closed in a single stroke. An exemplary ligatingdesign of this type is described in U.S. Pat. No. 2,610,631.

While workable and an improvement in many ways over othersuture-applying devices, ligators of the type described in the '631patent suffer from certain disadvantages. First, the ratio of sutureuptake to puller travel is limited to a factor of 2. While it would betheoretically possible to wrap the suture around a second post on theligator body and attach the free end of the puller (thus increasing theratio to a factor of 3), such additional turns of the suture wouldincrease the chances that the suture would become tangled while the loopapplier is in use. Additional turns further compromise the device byincreasing the friction between the suture and the posts, therebyreducing the ease of actuation. Moreover, the utility of the device islimited in laparoscopic and endoscopic or other cannula procedures wherethe applier must be introduced through a trocar sleeve, since thepresence of the suture on the exterior of the ligator increases thechanges that the suture will become tangled during introduction.Additionally, presence of the coupling mechanism between the puller andthe suture on the exterior of the device increases the opportunity forcontamination and jamming.

For these reasons, it would be desirable to provide improved devices andmethods for applying pre-tied ligating loops to body structures, wherethe devices and methods are suitable for applying large-diameterligating loops using a single device in a single hand. Such devicesshould be of relatively simple construction and should be relativelysimple to use. In particular, it would be desirable if the suture becontained completely or almost completely within the interior of thedevice and that the design reduce the opportunity for the suture tobecome entangled during use. It would be further desirable to providesystems which permit insertion of the suture through conventional trocarsleeves or other cannulas, where the suture is protected by a sheathwhich is automatically retracted as the suture is passed through thecannula.

2. Description of the Background Art

U.S. Pat. No. 2,610,631, is described above. U.S. Pat. No. 3,476,115,describes a ligating loop applier comprising a single tube having afrangible proximal end, where the proximal end is attached to a free endof the suture and may be broken off so that a suture loop at the distalend may be drawn closed. U.S. Pat. No. 5,129,912, describes a sutureapplying device, where a pre-tied suture loop is used for laparoscopicand endoscopic knot tying. Other devices are described in U.S. Pat. Nos.4,592,355; 3,985,138; 3,665,926; 659,442; U.S.S.R. Patent Publications1,169,630; 835,429; 552,077; and U.K. Patent 868,634.

SUMMARY OF THE INVENTION

According to the present invention, a suture applying and tighteningdevice comprises a hollow shaft which carries a length of suturetherethrough having a first free end and a second end which is formedinto a loop. In particular, the loop will be pre-tied with a slip knotwhich permits the loop to be tightened by pulling on the free end of thesuture while the knot is held in place. The knot in the pre-tied sutureloop will be held on the distal end of the shaft so that pulling back onthe free end of the suture through the sheath will tighten or close theloop about a body structure. Typically, the shaft will be a tube havingan axial lumen, and the free end of the suture will pass proximallythrough the lumen while the pre-tied knot is held on a distal port ofthe lumen.

In a first embodiment of the apparatus of the present invention, ahandle assembly is attached to the proximal end of the shaft, and thehandle assembly includes a slidably mounted puller and a pulley having asmall-diameter wheel and a large-diameter wheel. The small-diameterwheel and large-diameter wheel will usually be mounted coaxially, andwill more usually be formed integrally, so that they will rotate inunison. The free end of the suture will be attached to thelarge-diameter wheel, while a connector line will be secured between thesmall-diameter wheel and the puller. In particular, the puller will bemounted proximally of the pulley so that drawing proximally on thepuller will cause a length of the suture to be drawn proximally along orthrough the shaft. The length of the suture taken in by the pulley willbe some multiple or factor greater than the length of travel of thepuller, depending on the ratio between the small diameter and largediameter. Usually, large diameter will be at least twice the smalldiameter, resulting in a factor of 2 between the length of suture takenin and the length of puller travel. The ratio, however, may be greaterthan 2, often being 3, 4, or more.

It will appreciated that alternate actuator mechanisms may be providedwithin the interior of the handle assembly. For example, the actuatormay include a pulley assembly, generally as described above, where thesmall-diameter wheel is a gear wheel. The pulley may then be actuated bya pusher rod having a gear face which mates with the small wheel. Inthis way, pushing on the rod can cause rotation of the pulley, havingthe same mechanical advantages described above for the puller assembly.The actuator mechanism could also provide for a pulley mounted on thepuller. The free end of the suture could then be passed over the pulleyand attached to the interior of the handle assembly. Proximal actuationof the puller would then provide for the desired mechanical advantage inpulling back the suture. A variety of other equivalent mechanicalstructures could also be provided.

A method according to the present invention utilizing the firstembodiment of the apparatus thus comprises positioning a pre-formed loopof suture over the target body structure and thereafter translating theactuator relative to the shaft. The apparatus will be manipulated by thephysician using a single hand, typically with the index and middlefingers on the puller and thumb on the proximal end at the apparatus,typically on a thumb rest. A single stroke of the actuator will be allthat is required for closing even a relatively large-diameter sutureloop, having a diameter of 5 cm or larger.

A second embodiment of the apparatus of the present invention comprisesa shaft which carries a pre-tied suture loop in a manner similar to thatdescribed for the first embodiment. The second embodiment will alsoinclude a handle assembly attached to the proximal end of the shaft,wherein the handle assembly includes a mechanism for selectivelyengaging and translating the free end of the suture, whereby the freeend may be successively drawn proximally to close the loop, typically intwo or more strokes. The suture engaging and translating mechanismpreferably comprises a pair of opposed jaws, where each jaw includes anattached finger retainer and wherein the handle includes a thumbretainer. Thus, the treating physician may manipulate the device byplacing the index and middle fingers in or on the finger retainers andthumb against the thumb retainer, so that the jaws may be closed anddrawn proximally using the fingers in opposition to the thumb. Usually,the jaws will be spring-biased so that they remain open in the absenceof closing pressure from the physicians fingers. The jaws will alsousually include gripping surfaces which help secure the suture when thejaws are closed on one another and drawn proximally.

The apparatus according to the second embodiment will further includemeans for holding the free end of the suture under tension between eachstroke of the jaws. Usually, the holding means will comprise a supporttube attached to the proximal end of the suture, the support tubeextending through and frictionally engaging as aperture in the handle.Between each stroke of the jaws, the support tube maintains tension inthe suture until the jaws reengage the free end.

In a method according to the present invention utilizing the secondembodiment of the apparatus, the pre-formed suture loop is firstpositioned over the body structure and the jaws thereafter engagedagainst the free end of the suture which passes therebetween. Thetreating physician may then draw proximally on the jaws using the fingerretainers in opposition to the thumb. The process will usually berepeated one or more times in order to draw a sufficient length ofsuture to completely close the pre-tied loop. It will be appreciatedthat the device can close the loop of virtually any diameter using onlya single hand by repeating successive strokes using the jaws.

Any of the loop applying apparatus of the present invention may beutilized in a system for applying and tightening a suture loopcomprising a suture loop applier having a sheath slidably mounted on adistal end of the shaft. The sheath covers and protects the suture loopwhich extends from the distal end of the shaft, but may be proximallytranslated to expose the suture loop after it has been introducedthrough a narrow diameter trocar sleeve or other cannula to a targetsite. Typically, the sheath will include a protrusion near its proximalend configured to engage a point near the proximal end of the cannula.The cannula may include a restriction near its proximal end which willinterfere with the protrusion. Introduction of the sheath through thetrocar sleeve will thus result in an interference between the protrusionand the cannula, which prevents the sheath from passing entirely throughthe cannula, and causes the sheath to retract over the shaft of thesuture loop applier. Thus, the suture loop will be automatically exposedthrough the distal end of the cannula as the suture applier is insertedtherethrough using a single hand. In a preferred aspect, the cannulawill be combined with a stylet so that it may be self-introduced. Thus,the suture applier can be positioned at any insertional location withoutthe need for a pre-positioned incision or trocar. The cannula and styletmay be of substantially smaller diameter than conventional trocars,minimizing trauma in the patent.

Alternative embodiments of the suture applying system include a cannulahaving a restriction at the proximal end, the distal end, or a pointmidway between the two ends. These restrictions engage the distal end ofthe sheath which is configured to be larger than the restriction thuscausing the sheath to be retracted and allowing the suture to beuncovered. These embodiments thus prevent the sheath from travellingthrough the distal end of the cannula and into a patient's body cavity.

Other alternative embodiments of the suture applying system include asheath having a score along an axial line thereby allowing the sheath tosplit as the handle is advanced through the sheath. With thisconfiguration, longer sheath lengths which accommodate larger loop sizescan be used. Alternatively, the sheath is configured to be axiallycompressible. This may be accomplished by constructing the sheath of abraided or woven mesh material, or by a tube having a convoluted wall.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevational view of a first embodiment of the sutureapplying device of the present invention.

FIG. 1A illustrates an alternative actuation mechanism for the firstembodiment of the suture applying device of the present invention.

FIG. 2 is a top plan view of the suture applying device of FIG. 1, withportions broken away.

FIG. 3 is a detailed view of the pulley system of the suture applier ofFIGS. 1 and 2, taken along line 3--3 of FIG. 2.

FIG. 4 is a top plan view of the suture applier of FIGS. 1 and 2, shownwith the suture loop in a closed configuration.

FIG. 5 is a top plan view of a second embodiment of the suture applierof the present invention, shown with portions broken away.

FIG. 6 is a top plan view, similar to FIG. 5, except that the free endof the suture has been retracted and the suture loop has been partiallyclosed.

FIG. 7 is a side elevational view with portions broken away of analternative embodiment of a suture applying device constructed inaccordance with the principles of the present invention.

FIG. 8 is a top plan view with portions broken away of the embodiment ofthe suture applying device of FIG. 7.

FIG. 9A is a perspective view of a suture applying system constructed inaccordance with the principles of the present invention.

FIG. 9B is a perspective view of the stylet and cannula of the sutureapplying system of FIG. 9A.

FIGS. 10A-10F illustrate use of the system of FIG. 9 in applying sutureto a severed body duct according to the method of the present invention.

FIGS. 11-13 are a cross sectional views of alternative suture applyingsystems constructed in accordance with the principles of the presentinvention.

FIG. 14 is a perspective view of a suture applying system showing thesheath being separated along an axial line as the handle is advancedthrough the sheath.

FIG. 15 is a perspective view of a suture applying system showing asheath constructed with a compressible tube.

FIG. 16 is a perspective view of a suture applying system showing asheath constructed with a braided or woven mesh material.

DESCRIPTION OF SPECIFIC EMBODIMENTS

The suture applying device of the present invention comprises anelongate shaft which carries a suture loop at its distal end. The sutureloop includes a pre-tied slip knot and a free end extending from theslip knot so that pulling on the free end in a proximal direction willtighten the loop over a target body structure. The present inventionfurther comprises a mechanism on the device for pulling on the free endof the suture in a proximal direction, where the mechanism enables thetreating physician to proximally draw sufficient length of suture toclose even relatively large suture loops. In a first embodiment, themechanism comprises a pulley assembly, as described in more detailhereinafter. In a second embodiment, the mechanism comprises a pair ofspring-biased opposed jaws, as described in more detail hereinafter.

The shaft of the suture applying device will be an elongate structure,typically being a tube or cylinder having a diameter small enough to beused in laparoscopic, endoscopic, and similar procedures. Typically, theshaft will have a width or diameter in the range from about 1.5 mm to 2mm. The length of the shaft will be sufficient to permit use of thedevice in such laparoscopic, endoscopic, and similar procedures,typically being from about 20 cm to 30 cm, usually being from 23 cm to25 cm. It will be appreciated that the shaft diameter need not beuniform over its entire length and that the narrow diameter portion needonly be long enough to permit access through a narrow incision, trocarsleeve or other cannula being used in the procedure. The shaft may becomposed of a variety of materials, usually being surgical stainlesssteel, polycarbonate resin, or the like. A handle assembly will beattached to the proximal end of the shaft and will be used by thetreating physician to manipulate the device during use. The handle willtypically comprise an elongate body having a hollow interior anddefining a track for a puller or jaw mechanism for retracting the freeend of the suture, as described in more detail hereinafter. The handlemay also be formed from a variety of materials, such as surgicalstainless steel, polycarbonate resin, and the like. The puller or jawmechanism will usually include a pair of finger retainers, i.e. "ears",or rings, disposed on or within the track, and an opposed thumb retaineror ring disposed on the proximal end of the handle. In this way, theuser can hold the handle between the middle and index fingers whileapplying proximal force on the finger retainers.

Referring now to FIGS. 1-4, a first specific embodiment 10 of the sutureapplying device of the present invention will be described. The sutureapplying device 10 comprises a shaft 12 having a proximal end 14 and adistal end 16. An elongate handle 18 is secured at its distal end 20 tothe proximal end 14 of shaft 12. Handle 18 includes a hollow interiorand defines an elongate slot 22. A puller 24 including a pair offinger-retaining ears 26 is slidably mounted in the slot 22 so that itmay be shifted between a distal position (FIGS. 1 and 2) and a proximalposition (FIG. 4). The handle 18 will typically terminate in a thumbretainer, such as thumb ring 28 at its proximal end. In this way, thetreating physician may hold the device 10 with the thumb within thumbretaining ring 28 and middle and index fingers on the finger retainingears 26, in a conventional manner.

A length of suture 30 includes an open loop 32 and a free end extendingproximally from the open loop. The open loop 32 is held outside thedistal tip 16 of shaft 12 with a slip knot 34 being located adjacent anopen distal port of the lumen in the shaft. The free end of suture 30passes through the open port and proximally through the lumen of theshaft 12. After passing through the lumen, the free end of suture 30enters the interior of housing 18 where it is received on alarge-diameter wheel 40 of a pulley assembly 42, best illustrated inFIG. 3. The pulley assembly 42 also includes a small-diameter wheel 44,and the large-diameter wheel 40 and small-diameter wheel are mountedcoaxially on a shaft 46 held in a pair of opposed bearings 48 in thehousing.

A connector line 50 is secured between the small-diameter wheel 44 andthe puller 24. When the puller is in its proximal-most position, asillustrated in FIGS. 1 and 2, the connector line 50 will be wrappedaround the small-diameter wheel 44 a number of times, typically at leastabout 5 times. The free end of suture 30, in contrast, will be attachedto the large wheel 40, but will not necessarily be wrapped around thewheel at all. In this way, as the puller 24 is axially translated alongslot 22 in a proximal direction, the connector line 50 will unwind andcause the pulley assembly 42 to rotate. Such rotation, in turn, willcause the large-diameter wheel 40 to take-in the free end of suture 30.In particular, the length of suture 30 being taken in for each turn ofthe pulley will be greater than the length of connector line 50 which isdrawn out. The ratio between the suture and length of connector line 50will be equal to the ratio between the large-diameter andsmall-diameter. That is, when the large-diameter is twice thesmall-diameter, for each unit length of connector line 50 which is drawnproximally by puller 24, two unit lengths of the free end of suture 30will be drawn in on large-diameter wheel 40. This ratio can, of course,be increased by increasing the size of large-diameter wheel 40 relativeto small-diameter wheel 44 or decreasing the size of the small-diameterwheel relative to the large-diameter wheel.

As illustrated in FIG. 4, when the puller 24 has been drawn fullyproximally within the slot 22, the loop 32 will be essentiallycompletely closed. The initial size of loop 32 may be arbitrarily large,with the ratio between the large-diameter and small-diameter beingselected to provide sufficient uptake length to close the loop. Usually,the loop 32 will be at least 5 cm in diameter, but may be as large as7.5 cm in diameter, or even as large as 10 cm in diameter. The ratiobetween the large diameter and small diameter will usually be at leastabout 2, frequently being at least about 3, and sometimes being 4 orgreater.

Referring now to FIG. 1A, an alternate actuation mechanism for theembodiment of FIGS. 1-4 is illustrated. The actuation mechanism 100comprises pulley 102 including a large-diameter take-up wheel 104 and asmall-diameter gear wheel 106. An actuation rod 108 having a thumb rest110 and a gear face 112 is mounted within the device handle 114 so thatit may be translated axially by pressing on the thumb rest. The gearface 112 mates with the small-diameter gear wheel 106 so that proximalaxial movement of the rod 108 will cause counter-clockwise rotation ofthe pulley 102. Such rotation will take up a free end of suture 116,thus closing a suture loop (not illustrated) in a manner similar to thatdescribed above.

Referring now to FIGS. 5 and 6, a second embodiment 60 of the device ofthe present invention will be described. The device 60 includes a shaft62 having a proximal end 64 and a distal end 66. A length of suture 68is held within the shaft 62, generally as described for suture 30 inFIGS. 1-4, and includes a pre-tied loop 70 at its distal end.

A handle 72 is secured to the proximal end 64 of shaft 62 and includes ahollow interior with a pair of slots 74 formed along its length. Asuture engaging mechanism 76 is disposed within the interior of handle72 and comprises a pair of opposed jaws 78 which extend laterallyoutward through the slots 72. Each jaw 78 terminates in a fingerretainer 80, typically in the form of a finger ring, and the proximalend of the handle 72 terminates in a thumb retainer typically also aring 82.

The jaws 78 include opposed gripping surfaces 84 which are disposed neara fulcrum point where the jaws converge. Suture 68 extends through anaxial passage 86 formed through the engaging element 76. The suture alsopasses between gripping surfaces 84 of the jaws 78, so that the user mayclamp the gripping surfaces down on the suture by pressing inwardly onthe finger rings 80. Usually, this will be accomplished as the userholds the device using the thumb, middle finger, and index finger, in aconventional manner. The user may simply tighten on the finger retainingrings 80 using the middle and index fingers and thereafter draw theengaging member 76 proximally backward, to the configuration shown inFIG. 6. A single proximal stroke, as just described, will usually beinsufficient to close a relatively large pre-tied loop 70. Should theloop 70 need to be further tightened, the user may loosen the grip onfinger retaining rings 80 so that the gripping surfaces 84 disengage thesuture 68. The engaging element 76 may then be axially advanced in thedistal direction, the jaws again tightened using the finger rings 80,the suture again drawn proximally to further tighten loop 70. Suchtightening strokes can be repeated as many times as necessary to fullyclose the loop 70.

In a preferred aspect of the suture applying device 60, a support tube90 is attached to the proximal end of suture 68 and passes through anaperture 92 formed in the handle 72. The support tube will frictionallyengage an aperture 92 so that the free end of suture 68 is held in placewhen the jaws 78 are disengaged from the suture. This is particularlyhelpful while the suture loop 70 is being incrementally closed using thejaws 78 since it will inhibit or prevent slackening of the suture withinthe device.

Referring now to FIGS. 7 and 8, a further preferred embodiment 120 ofthe suture applying device of the present invention will be described.The device 120 includes a shaft 122 having a proximal end 124 and adistal end 126. An elongate handle 128 is secured at its distal end 130to the proximal end 124 of the shaft 122. Handle 128 includes a hollowinterior and defines an elongate slot 132. A puller 134 includes a pairof finger-retaining ears 136 slidably mounted in the slot 132 so that itmay be shifted between a distal position (shown in full line in FIG. 8)and proximal position (shown in broken line). The handle 128 willtypically terminate in a thumb retainer, such as the thumb ring 138 atits proximal end. In this way, the treating physician may hold thedevice 120 with the thumb within thumb-retaining ring 138 and middle andindex fingers on the finger retaining ears 136, in a conventionalmanner.

A length of suture 140 includes an open loop 142 and a free endextending proximally from the open loop. The open loop 142 is heldoutside the distal tip 126 of shaft 122 with a slip-knot 144 beinglocated adjacent an open distal port of the lumen in the shaft, theslip-knot being larger than the distal port to prevent passagetherethrough. The free end of the suture 140 passes through the openport and proximally through the lumen of shaft 122. After passingthrough the lumen, the free end of the suture 140 enters the interior ofhousing 128, where it is received over a pulley 150 mounted on puller134. The free end of suture 140 is secured to an anchor point 151 fixedto the interior of housing 128. In this way, proximal retraction of thepuller 34 draws the free end of suture 140 proximally at a rate twicethat of the rate which the puller is drawn. It will be appreciated thatan even greater increase in the rate of suture translation could beachieved by placing a second pulley (not illustrated) on the housing andpassing the free end of the suture over the second pulley and attachingit to the puller. In this way, a 3:1 ratio of uptake to pulleywithdrawal could be achieved.

Referring now to FIG. 9A, a suture applying system 150 includes a sutureapplying device 152 which may take the form of any of the previouslydescribed embodiments. The suture applying device will include a housing154, an actuator 156, and a shaft 158. The system 150 further comprisesa sheath 160 slidably disposed over a distal portion of the shaft 158. Asuture to be applied by the device has, as described above, a free endcarried within shaft 158 coupled to actuator 156 at its proximal end andextending through a distal port in shaft 158 to a loop 162 residingoutside of the shaft. Loop 162 may be disposed distal to the distal endof shaft 158, or adjacent a lateral surface of shaft 158, surrounded bysheath 160. Loop 162 is thereby protected within the sheath, but may beexposed by sliding the sheath 160 in a proximal direction over the shaft158.

The sheath 160 is intended to be introduced through a trocar sleeve orother cannula 164 which is sized to receive the sheath within a centrallumen 166 thereof. The cannula 164 may comprise a restriction 168,illustrated as a narrowing of central lumen 166 in the proximal end ofthe cannula. Restriction 168 is sized to mate with a protrusion 170,illustrated as a flare at the proximal end of sheath 160. Protrusion 170may alternatively comprise a bump, retaining ring, rim, or similarstructure. In this way, the sheath 160 may be freely introduced throughthe trocar 164 until the protrusion 170 engages the restriction 168.Alternatively, the cannula may be of substantially constant interiordiameter without a restriction, in which case the protrusion wouldengage the proximal end surface of the cannula. At that point, furtherdistal travel of the sheath is prevented, and the sheath will beautomatically retracted relative to the distal end of shaft 158 as thesuture applier is further pushed through the cannula. Thus, loop 162will be introduced out the distal end 172 of the cannula 164, where itwill be available for use at a desired target location.

The suture applying system of the present invention is particularlyadvantageous due to the reduced trauma the system inflicts upon thepatient. This is accomplished by providing a self-introducing cannula168 having a diameter smaller than conventional trocar sleeves whicheliminates the need for positioning an additional trocar sleeve tointroduce the suture applier. As shown in FIG. 9B, the self-introducingcannula 168 includes a stylet 180 having a sharpened distal tip 182 forpenetrating tissue, a rigid shaft 184, and a knob 186 on the proximalend of the shaft suitable for grasping with the fingers and pushing withthe thumb. Stylet 180 may be slidably positioned in central lumen 166 ofcannula 164 with distal tip 182 of the stylet extending beyond distalend 172 of the cannula. In this way, the cannula 164 may be positionedin the body of the patient by exerting a distal force on knob 186 suchthat tip 182 penetrates body tissue. Taper 188 on cannula 164facilitates introduction of the cannula through the penetration createdby stylet tip 182. Once the cannula has been positioned as desired,stylet 180 may be removed from central lumen 166, to allow introductionof the suture applier.

In a preferred embodiment, the cannula 164 and stylet 180 will be ofsignificantly small cross-section than conventional trocars. Centrallumen 166 of the cannula will have a diameter large enough to facilitateintroduction of stylet 180 and shaft 158 of the suture applier, whichwill be as small as 12-14 gauge or smaller for a suture size 0. Forsmall suture sizes, such as size 2-0, shaft 158 and stylet 180 may be ofeven smaller diameter. As a result, the outer diameter D of cannula 164may be as small as 2.5 mm or less, as compared to conventional trocarswhich have an outer diameter typically in the range of 5 mm to 6 mm. Thesmall diameter of the self-introducing cannula of the suture applyingsystem of the present invention therefore results in significantly lesstrauma than devices which require the use of conventional trocars.

Use of the suture applying system 150 of the invention is illustrated inFIGS. 10A-10F. A body structure S to be sutured is located within a bodycavity such as the abdomen, beneath a body surface B, which may be, forexample, the abdominal wall (FIG. 10A). Cannula 164 may beself-introduced using an internal stylet 180 having a sharpened tip 182which extends from the distal end of the cannula. In this way, thedistal end of the cannula may be positioned adjacent the body structureS, as illustrated in FIG. 10B. The stylet is then withdrawn and thesuture applier introduced through the proximal end of the cannula 164with sheath 160 surrounding a distal portion of shaft 158, asillustrated in FIG. 10C. The suture applier is fully introduced untilprotrusion 170 of sheath 160 engages restriction 168, causing the distalend of shaft 158 carrying suture loop 162 to emerge from the distal endof cannula 164, as illustrated in FIG. 10D. The suture loop 162 may thenbe positioned over the body structure S, as illustrated in FIG. 10E, andthe suture loop 162 tightened by drawing proximally on puller 156, asillustrated in FIG. 10F. The tightened suture loop may then be cut,typically using separately introduced cutters, and the suture applierand cannula 164 removed from the body cavity.

Alternative embodiments of the suture applying system 150 are shown inFIGS. 11-13. These embodiments include a sheath protecting the sutureloop similar to FIG. 9. Unlike the system in FIG. 9, however, theseembodiments prevent the sheath from intruding into the body cavity. Thisis accomplished by a restriction at any point along the cannula whichretracts the sheath to expose the loop. Thus, the loop is protected bythe sheath while in the cannula until the restriction is reached. Atthis point, the sheath is retracted exposing the loop during the loop'sremaining travel through the cannula. Such a configuration isparticularly useful when space in the abdominal cavity is limited, as isthe case with thin patients and/or with use in the lower abdominalcavity, since the sheath is not allowed to extend through the cannula.Further, because the sheath is retracted prior to passing through thedistal end of the introducer cannula, longer sheath lengths, and thuslarger loop sizes, can be used even while working with limited abdominalcavity space.

The embodiment shown in FIG. 11 is configured so that sheath 260 engagesthe proximal end of the cannula 264 enabling the suture to advancethrough the central lumen 266 of the cannula 264 without the sheath 260.Preferably, engagement will be accomplished by sizing the outer diameterof the sheath 260 to be larger than the inner diameter of the centrallumen 266 of the cannula 264. The outer diameter of the shaft 258 (shownin broken line) has a diameter less than the diameter of the centrallumen 266 of the cannula 264 so that is can pass through the cannula.With this configuration, the sheath 260 may be introduced into thecannula 264 until the distal end of the sheath 260 contacts therestriction 268 in the cannula 264 (which is equal to the inner diameterof the central lumen 266). Thus, the shaft 258 passes through the lumen266 while the sheath 260 will be automatically retracted over the shaft258 as the shaft 258 is further advanced through the cannula 264. Thus,loop 262 will be able to pass out the distal end 272 of the cannula 264and into the patient's body cavity. Alternatively, the sheath 260 couldhave a protrusion (not shown) at its distal end to engage the proximalend of the cannula 264.

In FIG. 12, a distal end of sheath 360 engages cannula 364 at a midpointbetween its proximal and distal ends. Preferably, this will beaccomplished by forming a restriction or narrowing 368 in the middle ofthe central lumen 366 so that the distal end of the sheath 360 willengage the cannula 364 at the restriction 368 thereby retracting thesheath 360 and exposing the suture. The suture may then be extendedthrough the distal end of the cannula 364 as previously discussed.

The embodiment in FIG. 13 is similar to the embodiment in FIG. 12 exceptthat the restriction or narrowing 468 is located at or near the distalend of the cannula 464. With this configuration, the sheath 460 coversthe suture until the sheath 460 engages restriction 468 therebyuncovering the suture and allowing it to extend through the cannula 464as previously discussed.

The embodiments discussed in connection with FIGS. 11-13 allow thesheath to be longer than the sheath in FIG. 9 because the sheath doesnot extend into the body cavity. As sheath lengths are increased withthese embodiments, however, the distance that the shaft may beintroduced into the body cavity is reduced because of earlier contactwith the sheath and the handle of the suture applier. Thus, acollapsible sheath structure as shown in FIGS. 14-16 can be used toallow further travel of the shaft into the body cavity while allowinglonger sheaths and larger loop sizes.

In FIG. 14, the suture applying system 550 has a sheath 560 that willsplit axially as the handle 554 is axially advanced in the distaldirection (arrow 555). To facilitate splitting, the sheath 560 can havea score 561 along an axial line. As the sheath 560 is split, it willpeel off the shaft 558 allowing further passage of the shaft 558 intothe abdominal cavity. With this configuration, longer sheath lengthswhich accommodate larger loop sizes, can be used while maintaining anadequate proximity between the handle of the suture applier and thetarget anatomy.

Alternatively, as shown in FIGS. 15 and 16, the sheath can beconstructed of a compressible tube or the like so that the tube axiallycollapses as a force is applied to the suture applier. As shown in FIG.15, sheath 660 can have a convoluted wall which permits the shaft tofold or "accordion" as the handle 654 is advanced. As shown in FIG. 16,the sheath 760 can be constructed of a braided or woven mesh material orthe like that collapses under a load.

Although the foregoing invention has been described in some detail byway of illustration and example, for purposes of clarity ofunderstanding, it will be obvious that certain changes and modificationsmay be practiced within the scope of the appended claims.

What is claimed:
 1. A system for applying a suture loop through acannula having a central lumen, said system comprising:a suture loopapplier including a handle connected to a shaft, a length of suture loophaving a free end and a loop at another end, wherein the loop extendsfrom a distal end of the shaft; and a sheath slidably mounted on theshaft to move between an extended position wherein the suture loop iscovered and a retracted position wherein the suture loop is uncovered.2. A system as in claim 1, wherein a distal end of the sheath isconfigured to engage with a proximal end of the cannula, wherebyengagement of the distal end of the sheath with the proximal end of thecannula will cause the sheath to slide proximally on the shaft allowingthe suture to advance entirely through the lumen uncovered by thesheath.
 3. A system as in claim 2, wherein the sheath has an outerdiameter that is greater than an inner diameter of the central lumen ofthe cannula, so that the distal end of the sheath is engagable with theproximal end of the cannula.
 4. A system as in claim 1, furthercomprising a protrusion at a proximal end of the sheath for engagementwith a proximal end of the cannula, whereby the suture is advancablethrough the lumen while covered by the sheath until the protrusionengages the cannula to retract the sheath.
 5. A system as in claim 4,further comprising a restriction at the proximal end of the cannula forengagement with the protrusion of the sheath.
 6. A system as in claim 1,wherein a distal end of the sheath is configured to engage with a distalend of the cannula, whereby the suture is allowed to advance through thelumen covered by the sheath until engagement of the distal end of thesheath with the distal end of the cannula.
 7. A system as in claim 6,further comprising a restriction at the distal end of the cannula forengagement with the sheath.
 8. A system as in claim 1, wherein a distalend of the sheath is configured to engage the cannula at a midpointbetween a proximal and a distal end thereof, whereby the suture iscovered by the sheath during a portion of the sheath's advancementthrough the cannula lumen.
 9. A system as in claim 8, further comprisinga restriction at the midpoint of the cannula for engagement with thesheath.
 10. A system as in claim 1, wherein the sheath is scored alongan axial line to facilitate splitting as the handle is advancedtherethrough.
 11. A system as in claim 1, wherein the sheath is axiallycompressible.
 12. A system as in claim 11, wherein the sheath isconstructed of a braided or woven mesh material, whereby the sheath willcompress upon contact with the handle.
 13. A system as in claim 11,wherein the sheath is a tube having a convoluted wall.
 14. A system forapplying a suture loop through a cannula having a central lumen, saidsystem comprising:a suture loop applier including a handle connected toa shaft, a length of suture loop having a free end and a loop at anotherend, wherein the loop is held at a distal end of the shaft; a sheathslidably mounted on the distal end of the shaft, said sheath coveringthe suture loop, said sheath having an outer diameter greater than aninner diameter of the central lumen of the cannula whereby the sheath isprevented from entering the proximal end of the central lumen of thecannula; said shaft having an outer diameter less than the innerdiameter of the cannula such that the shaft may be extended through thecannula while the sheath is prevented from entering the central lumen ofthe cannula, thereby causing the sheath to slide proximally on the shaftto expose the suture loop through a distal end of the cannula.
 15. Amethod for applying a suture loop into a body cavity, said methodcomprising:introducing a cannula having a central lumen into the bodycavity; introducing a suture loop protected by a sheath into thecannula; engaging the cannula with the sheath so that the sheath is heldstationary relative to the cannula; and advancing the suture loopthrough the lumen and into the body cavity.
 16. A method as in claim 15,wherein the step of introducing the cannula includes introducing thecannula with an internal stylet, the method further comprising removingthe stylet prior to introducing the suture loop and the sheath into thecannula.
 17. A method as in claim 15, further comprising a step ofplacing the loop around a body structure in the body cavity andtightening the loop around the structure after the advancing step.
 18. Amethod as in claim 15, wherein the engaging step includes engaging aproximal end of the cannula with a distal end of the sheath, and theadvancing step includes advancing the suture entirely through the lumenwithout the sheath.
 19. A method as in claim 15, wherein the engagingstep includes engaging a distal end of the cannula with a distal end ofthe sheath so that the suture is covered by the sheath as it advancesthrough the lumen.
 20. A method as in claim 15, wherein the engagingstep includes engaging a proximal end of the cannula with a proximal endof the sheath, and the advancing step includes advancing the suturethrough the lumen covered by the sheath until a protrusion engages thecannula to retract the sheath.
 21. A method as in claim 15, wherein theengaging step includes engaging the cannula at a midpoint between theproximal and distal ends thereof with a distal end of the sheath, sothat the suture is covered by the sheath during at least part of theadvancing step.
 22. A method for applying a suture loop into a bodycavity, said method comprising:introducing a cannula into a patient;providing a suture applier including a shaft, a length of suture havinga free end and a pre-formed loop, a handle connected to a proximal endof said shaft, and a sheath on the distal end of the shaft protectingthe preformed loop; introducing the suture applier and the sheath intothe cannula: and exposing the suture loop through the distal end of thecannula.
 23. A method as in claim 22, wherein the step of introducingthe cannula includes introducing the cannula with an internal stylet,the method further comprising a step of removing the stylet prior tointroducing the suture applier and the sheath into the cannula.
 24. Amethod as in claim 22, further comprising the steps of engaging aproximal end of the cannula with a distal end of the sheath andadvancing the suture entirely through the lumen without the sheath. 25.A method as in claim 22, further comprising the steps of engaging adistal end of the cannula with a distal end of the sheath and advancingthe suture so that the suture is covered by the sheath as it advancesthrough the lumen.
 26. A method as in claim 22, further comprising thesteps of engaging a proximal end of the cannula with a proximal end ofthe sheath and advancing the suture through the lumen covered by thesheath until a protrusion engages the cannula to retract the sheath. 27.A method as in claim 22, further comprising the steps of engaging thecannula at a midpoint between the proximal and distal ends thereof withit distal end of the sheath and advancing the suture so that the sutureis covered by the sheath during a portion of the sheath's advancementthrough the cannula lumen.
 28. A method as in claim 22, furthercomprising a step of separating the sheath along an axial score as thehandle contacts the sheath and is advanced therethrough.
 29. A method asin claim 22, further comprising a step of axially compressing the sheathas the handle contacts the sheath and is further advanced.
 30. A methodfor applying a suture loop into a body cavity, said methodcomprising:introducing a cannula having a central lumen into a patient;providing a suture applier including a shaft, a length of suture havinga free end and a pre-formed loop, a handle connected to a proximal endof said shaft, and a sheath on the distal end of the shaft protectingthe preformed loop, the sheath having an outer diameter greater than aninner diameter of the central lumen of the cannula, the shaft having anouter diameter less than the inner diameter of the central lumen of thecannula; introducing the suture applier and the sheath into the cannulathereby retracting the sheath along the shaft and exposing the sutureloop through the distal end of the cannula.
 31. Apparatus for applyingand tightening a suture loop, said apparatus comprising:a hollow shafthaving a proximal end and a distal end; a length of suture having a freeend and a loop at another end, wherein the loop is held at the distalend of the shaft and the free end of the suture extends through thehollow shaft to the proximal end; a handle assembly comprising a housinghaving a protected interior attached to the proximal end of the shaft,said handle assembly including a slidably mounted actuator, saidactuator comprising a puller; and a pulley on the puller positionedentirely within the protected interior, wherein the free end of thesuture travels around the pulley and is secured to the handle, saidpulley coupling the puller to the free end of the suture so that thefree end is drawn proximally by the puller at a faster rate than thepuller, whereby drawing proximally on the puller will tighten the sutureloop.
 32. Apparatus for applying and tightening a suture loop, saidapparatus comprising:a hollow shaft having a proximal end and a distalend; a length of suture having a free end and a loop at another end,wherein the loop is held at the distal end of the shaft and the free endof the suture extends through the hollow shaft to the proximal end; ahandle assembly comprising a housing having a protected interiorattached to the proximal end of the shaft, said handle assemblyincluding a slidably mounted actuator, said actuator comprising apusher; and a pulley rotatably mounted in the interior of the housinghaving a small gear wheel and a large uptake wheel attached to the freeend of the suture, wherein the pusher includes a gear face which mateswith the gear wheel, said pulley coupling the pusher to the free end ofthe suture so that the free end is drawn proximally by the pusher at afaster rate than the pusher, whereby drawing proximally on the pusherwill tighten the suture loop.
 33. Apparatus for applying and tighteninga pre-tied suture loop, said apparatus comprising:a shaft havingproximal and distal ends; a length of suture having a free end and aknotted loop at the other end, wherein said knotted loop is held on thedistal end of the shaft; and a handle assembly attached to the proximalend of the shaft and having means for selectively engaging andproximally translating the free end of the suture, whereby the free endmay be successively engaged and drawn proximally to close the knottedloop.
 34. Apparatus as in claim 33, wherein the shaft is a tube having alumen which receives the free end of the suture, wherein the loop isheld on an open distal port of the lumen.
 35. Apparatus as in claim 33,wherein the loop has a diameter which is larger than a size which can bedrawn closed around an object in a single stroke of the engaging means.36. Apparatus as in claim 33, wherein the means for selectively engagingand translating the free end of the suture comprises a pair of opposedjaws, wherein each jaw has an attached finger retainer and the handleincludes a thumb retainer, whereby the apparatus can be manipulatedusing the thumb and two fingers of a single hand.
 37. Apparatus as inclaim 36, wherein the opposed jaws are spring-biased away from eachother.
 38. Apparatus as in claim 37, wherein the opposed jaws defineopposed gripping surfaces which firmly grip the suture when the jaws areclosed together.